Colorectal cancer
Conditions
Interventions
GE-137 or placebo
Sponsors
GE Healthcare
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers: (1) The subject is >=18 and = 45 years old at screening. (2) Female subjects need to be either surgically sterile, post menopausal, or pre menopausal with a negative urine pregnancy test (3) The subject has high suspicion of CRC. (4) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed. (5) The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening . (6)The subject*s screening ECG and clinical laboratory tests are within normal limits. (7)The subject*s body mass index is
Exclusion criteria
Exclusion criteria: Healthy Volunteers (1) If female, the subject is lactating or pregnant. (2) The subject has been previously included in this study. (3) Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year. (4) Loss of blood outside the limits of Sanquin within 3 months prior to screening. (5) The subject has received any prescription or non-prescription medication regularly between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted. ;Subjects with High Suspicion of Colorectal Cancer (1) If female, the subject is lactating or pregnant. (2) The subject is being treated or has been treated with chemotherapy or radiation within the 3 months before enrolment. (3) A biopsy has been obtained from the colon within the 3 weeks before enrolment. (4) The subject has been previously included in this study. (5) Treatment with another IMP within 3 months prior to screening or more than 4 times in the past year. (6) Loss of blood outside the limits of Sanquin within 3 months prior to screening. (7) The subject has had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted. (8) The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of GE-137 in healthy volunteers and patients with high suspicion of colorectal cancer, using standard safety measures | — |
Secondary
| Measure | Time frame |
|---|---|
| -To detemine the optimal dose of GE-137 and the optimal timing between GE-137 dosing and endoscopy. -To determine if GE-137 detects areas of increase fluorescence in the colon that correlate with pathology and c-Met expression in patients with high suspicion of CRC | — |
Countries
Netherlands
Outcome results
None listed